fMRI of Theory of Mind in Schizophrenia and Bipolar Disorder

Not Applicable

• Conditions: Bipolar Disorder, Schizophrenia
• Interventions: Behavioral: IRMf; Behavioral: Mini International Neuropsychiatric Interview; Behavioral: Positive And Negative Syndrom Scale; Behavioral: Young Mania Rating Scale; Behavioral: Hamilton Depression Scale

• Registration Number: NCT02834182
• Lead Sponsor: CHU de Reims

Brief Summary

Theory of mind (TOM), a main component of social cognition processes, refers to the capacity to infer one's own and other person's mental states. Deficits in social cognition are found in patients with schizophrenia and bipolar disorder. The purpose of this study is to compare the neurofunctional profiles of schizophrenic patients, bipolar patients and healthy participants during the performance of a TOM task. Results may help to understand the neural bases of the impairments in social cognition in schizophrenia and bipolar disorder, which may in turn help to propose potential new psychosocial therapeutic approaches in these disorders.

Detailed Description

Theory of mind (TOM) refer to the cognitive ability to attribute mental states to others, which plays an essential role in social communications and interactions between individuals. In several recent papers, it was shown that TOM is impaired in schizophrenia and bipolar disorder. This impairment strongly affects the quality of life in patients suffering from these disorders. The investigators study aims to explore the neural correlates of TOM in schizophrenic and bipolar patients, in comparison with those of healthy participants. These studies will be conducted on 30 schizophrenic patients, 30 bipolar patients, and 60 healthy participants, matched on age and educational level to each patient group. The investigators expect that the study of combined behavioral (neuropsychological tests) and neuro-anatomical data will allow to understand the pathophysiology of the alteration of social cognition processes in these illnesses.

Study Timeline

• Status Verified: 2016-06
• Study First Submitted: 2016-06-24
• Study Start: 2016-07
• Study First Submitted QC: 2016-07-12
• Last Update Submitted: 2016-07-12
• Study First Posted: 2016-07-15
• Last Update Posted: 2016-07-15
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Patients :

• Men or women aged from 18 to 65 years-old, right-handed, with a diagnosis of bipolar -disorder or schizophrenia, according to the DSM-5 criteria
• Native French speaker
• No substantial change in treatment for 2 weeks preceding study enrollment
• Able to provide informed written and verbal consent

Healthy Controls :

• Men or women aged from 18 to 65 years-old, right-handed
• Native French speaker
• Able to provide informed written and verbal consent

Exclusion Criteria

Patients :

• A recent alcohol and/or drug abuse or dependence (in the last six months)
• A significant general medical illness, including neurological disorders or head trauma
• A sensorial impairment uncorrected (visual and/or hearing)
• Contraindication to the use of MRI
• Persons under legal incapacity
• Persons who are not covered by national health insurance

Healthy Controls :

• Severe chronic psychiatric disorders including Bipolar disorder and schizophrenia
• Depression diagnostic according to DSM-5
• A personal or first-degree-relative history of bipolar disorder, schizophrenia or schizoaffective disorder according to DSM-5
• A recent alcohol and/or drug abuse or dependence (in the last six months)
• A significant general medical illness, including neurological disorders or head trauma
• A sensorial impairment uncorrected (visual and/or hearing)
• Contraindication to the use of MRI
• People particularly protected by the law
• Persons who are not covered by national health insurance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bipolar Disorder patients and Schizophrenic patients	Mini International Neuropsychiatric Interview	-
Healthy Controls	IRMf	-
Healthy Controls	Hamilton Depression Scale	-
Bipolar Disorder patients and Schizophrenic patients	Young Mania Rating Scale	-
Healthy Controls	Young Mania Rating Scale	-
Bipolar Disorder patients and Schizophrenic patients	Positive And Negative Syndrom Scale	-
Healthy Controls	Mini International Neuropsychiatric Interview	-
Healthy Controls	Positive And Negative Syndrom Scale	-
Bipolar Disorder patients and Schizophrenic patients	IRMf	-
Bipolar Disorder patients and Schizophrenic patients	Hamilton Depression Scale	-

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Scale	Up to 15 days after inclusion
Neuropsychological test : Mini International Neuropsychiatric Interview (M.I.N.I.)	Up to 15 days after inclusion
Young Mania Rating Scale	Up to 15 days after inclusion
Scale for the Assessment for Thought, Language and Communication	Up to 15 days after inclusion

Trial Locations

Locations (1)

Chu de Reims; 🇫🇷 Reims, France